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GMP News No. 551
9 May 2005
New: The ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment
For this reason, during the past two years a working group whose participants came from different fields within the industry (pharmaceutical manufacturers, equipment suppliers, engineers) developed a guideline for an objective assessment of containment technologies.
About the Guide
The ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment provides a standard methodology for use in testing the containment efficiency of solids handling systems used in the pharmaceutical industry under closely defined conditions. It covers the main factors that affect the test results for specific contained solids handling systems, including material handled, room environment, air quality, ventilation and operator technique.
Environmental parameters are either set, or an allowable range of operation specified, prior to testing. Test materials, details of sampling, sampling equipment, and sampling location are all specified based on best practice within the industry.
The Guide specifies the use of a surrogate test material and the methodology described identifies the critical factors that need to be controlled and monitored during the test. This includes guidance on the essential features of the test room with recommendations for finishes, air quality, and ventilation. It also addresses operator clothing and duties during the test. The test material properties are specified, e.g., particle size distribution. Sampling requirements are defined including positions of samplers and duration of monitoring, together with monitor types. Also identified are the analysis details together with the requirements of the final report.
This Guide provides information specific to various types of equipment and includes descriptions of each system, together with air sample and swab positions, and describes how data should be recorded, to allow interpretation by suitably qualified persons.
If you want to hear more about current GMP/FDA engineering aspects, we recommend our 4-day intensive training on pharmaceutical engineering in Barcelona from 31 May to 3 June 2005.
You can order the ISPE Guideline if you click here.